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NCT00628836 · ClinicalTrials.gov registry record · Phase 1
Treatment of Shoulder Subluxation in Chronic Stroke Patients
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00628836 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 30 participants.
The verdict
NCT00628836, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It compares electrical stimulation with surface electrodes (stimulation through the skin) with intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION® group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2 sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy. If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more intense therapy is carried out for another 6 weeks. Treatment is similar in the surface electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of 30 subjects is expected to complete the study.
Interventions
- DEVICE BION stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00628836
The ClinicalTrials.gov registry entry for NCT00628836 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BION stimulation is the first listed.
NCT00628836 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00628836 about?
NCT00628836 is a clinical study titled "Treatment of Shoulder Subluxation in Chronic Stroke Patients". The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It compares electrical stimulation with surface electrodes (stimulation through the skin) with intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator (BION). Subjects are put eith...
What is the current status of trial NCT00628836?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2001-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00628836?
The interventions under investigation include: BION stimulation (DEVICE).
Who is sponsoring clinical trial NCT00628836?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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